Holter of Movement in Patients with Multiple Sclerosis in Controlled Environment.

February 10, 2025 updated by: Laurent Servais

Holter of Movement in Patients with Multiple Sclerosis. Acti-SEP Study: Controlled Environment.

ActiSEP is a multicentric academic study. Ambulant patients with multiple sclerosis may be included on a voluntary basis. We plan to include a group of approximately 20 patients with MS.

This study include a unique evaluation in the laboratory of analysis of human movement. A set of tasks will be performed by patients wearing of two magneto-inertial sensors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • Centre Hospitalier Régional de la Citadelle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Confirmed MS diagnosis,
  • Over 18 years old,
  • Ambulant patients,
  • Signed informed consent,
  • No clinical and / or radiological relapse within 3 months.

Exclusion Criteria:

  • Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.
  • Any other previous or present pathology having an impact on motor function.
  • Recent surgery or trauma (less than 6 months) in the upper or lower limbs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MS patients
Ambulant patients with multiple sclerosis
Device: Actimyo°
Actimyo° is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
Device: IMU

IMU is a portable system of miniaturized inertial sensors for objective, instrumental, ambulatory, and validated analysis of normal and pathological human gait. Each miniaturized inertial sensor (2 cm × 0.7 cm × 0.5 cm) includes a triaxial accelerometer and a triaxial gyroscope.

These four inertial sensors are connected to a box by wires and are numbered 1 to 4. They must be attached - using adhesive tapes - on the participant's shoes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
95th centile of stride velocity
Time Frame: One day
95th centile of stride velocity obtained with magneto-inertial sensors and a motion capture device (meter/second).
One day
50th centile of stride velocity
Time Frame: One day
50th centile of stride velocity obtained with magneto-inertial sensors and a motion capture device (meter/second).
One day
95th centile of stride length
Time Frame: One day
95th centile of stride length obtained with magneto-inertial sensors and a motion capture device (meter).
One day
50th centile of stride length
Time Frame: One day
50th centile of stride length obtained with magneto-inertial sensors and a motion capture device (meter).
One day
Stance phase time
Time Frame: One day
Stance time over full stride time for each foot obtained with magneto-inertial sensors and a motion capture device (percentage).
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laurent Servais

Collaborators

Centre Hospitalier Régional de la Citadelle
SYSNAV

Investigators

  • Principal Investigator: Margaux Poleur, MD, CHR Citadelle-CHU liège

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2021

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (Actual)

May 17, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ActiSEP. Part 1.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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